Reimbursement & Market Access

Explains the 2026 CMS-FDA RAPID pathway for Breakthrough Devices, including Medicare coverage timing, eligibility, IDE study planning, and manufacturer preparation.

Buyer-side guide to Australia medical device registration costs, sponsor pricing models, flat fees versus hourly billing, and 3-year cash flow for ARTG inclusion across device classes.

Guide to Bangladesh DGDA device registration, covering Class A-D classification, Recipe Approval, registration, representative duties, import licensing, Bengali labeling, fees, and timelines.

Buyer-side guide to Brazil medical device registration costs, BRH pricing models, hourly versus flat fees, and 3-year cash flow for Class I/II notifications and Class III/IV registrations.

Buyer-side guide to Colombia Representative pricing models, comparing hourly, annual, and flat-fee registration costs with 3-year cash flow examples.

Guide to Costa Rica medical device registration through the Ministry of Health, covering classification, Spanish documents, legal and technical review, fees, timelines, and import permits.

Guide to CPT, HCPCS, and ICD coding strategy for medical device reimbursement, including when to seek new codes, AMA and CMS processes, payment systems, and market access planning.

Buyer-side breakdown of EU medical device registration costs in 2026, comparing EC REP hourly, registration-plus-annual, and flat-fee pricing with three-year scenarios.

Compare Hong Kong MDACS registration and LRP pricing models, including flat fees, hourly billing, 3-year cash flow, government fee status, and transition planning.

Register medical devices in Hong Kong through MDACS, including LRP duties, classification, reference pathways, Stage C procurement rules, fees, timelines, and transition planning.

Compare Indonesia LAR pricing models for medical device registration, including hourly, annual, and flat-fee structures, AKD/AKL cash flow, and importation fee mechanics.

Buyer-side guide to Malaysia medical device registration costs, comparing MAR hourly, annual, and flat-fee pricing models with 3-year cash flow scenarios and CAB-MDA-MAR fee structure.

Draft distribution agreements with EU MDR importer duties, FDA distributor controls, territory and exclusivity terms, PMS, vigilance, quality, and negotiation clauses.

Compare Medicare NCD and LCD pathways for medical devices, including evidence requirements, timelines, RAPID, Coverage with Evidence Development, MACs, and coverage strategy.

Compare Mexico MRH pricing models for medical device registration, including flat fees, hourly billing, three-year cash flow scenarios, switching steps, RFP points, and COFEPRIS pathways.

Register medical devices in New Zealand through Medsafe WAND, including sponsor duties, GHTF classification, adverse event reporting, labeling, TTMRA reliance, timelines, and costs.

Guide to CMS NTAP for medical devices, covering newness, cost, clinical improvement criteria, MEARIS submission, timelines, payment calculation, and pathway strategy.

Register medical devices in Pakistan with DRAP classification, establishment licensing, local agent duties, Urdu labeling, fees, timelines, and PMS.

Compare Singapore Registrant pricing models for HSA medical device registration, including hourly, annual, and flat-fee options with 3-year cash flow examples.

Compare Swiss CH-REP pricing models for 2026, including Pure Global flat fees, hourly billing, registration-plus-annual fees, and 3-year cash flow scenarios.